Senior Specialist – Quality & Compliance (Analytical Standards & Change Control)
Global Pharmaceutical Manufacturing Division
Job Overview
A leading global pharmaceutical organization is hiring a Senior Specialist – Quality & Compliance to support Analytical Standards and Change Control activities across new and existing products. The role ensures regulatory compliance, GMP adherence, and seamless implementation of analytical changes across global manufacturing and supply operations.
The position plays a key role in maintaining high-quality pharmaceutical standards, supporting cross-functional stakeholders, and ensuring timely execution of change control processes in a highly regulated environment.
Experience Required
Minimum 10 years of relevant professional experience in Quality, Laboratory Operations, Analytical Change Control, or related Pharmaceutical Manufacturing functions.
Educational Qualification
Bachelor of Science (BS) degree in Life Sciences, Engineering, Pharmacy, or a closely related scientific discipline.
Key Responsibilities
Manage Analytical Standards and Analytical Change Control activities for new products, in-line products, packaging, outsourcing, and compendial updates
Coordinate with Regulatory, Quality, Manufacturing, Supply Chain, and Technical teams to evaluate and approve analytical change controls
Ensure global alignment and execution of approved analytical changes across business units
Review, approve, and maintain Analytical Standard documentation in compliance with internal and regulatory requirements
Ensure compliance with cGMP guidelines, regulatory standards, and company quality policies
Support compendial review processes and implementation of regulatory updates through CAIT systems
Resolve cross-functional misalignments and prioritize change control execution across multiple stakeholders
Drive continuous improvement initiatives to enhance quality systems, efficiency, and compliance outcomes
Provide expert-level document review and quality approval for change control submissions
Maintain audit readiness and ensure adherence to global pharmaceutical regulatory expectations
Identify risks and escalate critical issues within the change control lifecycle
Required Skills & Competencies
Strong expertise in cGMP compliance and pharmaceutical quality systems
Experience in Analytical Standards and Change Control management
Knowledge of compendial requirements and regulatory frameworks
Strong cross-functional collaboration and stakeholder management skills
Ability to manage multiple priorities in a complex global environment
Excellent technical writing and documentation skills
Strong analytical thinking and problem-solving ability
Experience working in regulated pharmaceutical manufacturing environments
High attention to detail and strong decision-making capability
Ability to work independently and drive initiatives end-to-end
Preferred Skills
Exposure to global pharmaceutical regulatory operations
Experience in biologics, vaccines, or small molecule manufacturing environments
Familiarity with digital quality systems and compliance tools
Strong audit and inspection readiness experience
Advanced communication and leadership capabilities
Job Type & Work Model
Full-time | Regular Employment | Hybrid Work Model
Industry Domain
Pharmaceutical Manufacturing | Quality Assurance | Regulatory Compliance | Life Sciences
About the Role (SEO Summary)
This Senior Quality Specialist role is ideal for experienced pharmaceutical professionals specializing in analytical change control, GMP compliance, and global quality systems. The position focuses on ensuring regulatory compliance across manufacturing operations, supporting product lifecycle quality, and enabling consistent global standards in pharmaceutical manufacturing.
Uttar Pradesh :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
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Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
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Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Uxbridge | Renfrew | Australia | Mississauga | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
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Barcelona |Madrid :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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